The FDA on September 22, 2021 approved JAKAFI® (Ruxolitinib) for chronic Graft-Versus-Host Disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. JAKAFI® is a product of Incyte Corp.
Category: FDA Approvals
TIVDAK® (Tisotumab vedotin-tftv)
The FDA on September 20, 2021 granted accelerated approval to TIVDAK®, a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
TIVDAK® is a product of Seagen Inc.
CABOMETYX® (Cabozantinib)
The FDA on September 17, 2021, approved CABOMETYX® (Cabozantinib) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to Radioactive Iodine. CABOMETYX® is a product of Exelixis, Inc.
EXKIVITY® (Mobocertinib)
The FDA on September 15, 2021, granted accelerated approval to EXKIVITY® for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY® is a product of Takeda Pharmaceuticals, Inc.
BRUKINSA® (Zanubrutinib)
The FDA on September 14, 2021, granted accelerated approval to BRUKINSA® for adult patients with relapsed or refractory Marginal Zone Lymphoma (MZL) who have received at least one anti-CD20-based regimen. BRUKINSA® is a product of BeiGene.
BRUKINSA® (Zanubrutinib)
The FDA on August 31, 2021, approved BRUKINSA® for adult patients with Waldenström’s Macroglobulinemia (WM). BRUKINSA® is a product of BeiGene.
TIBSOVO® (Ivosidenib)
The FDA on August 25, 2021 approved TIBSOVO® (Ivosidenib) for adult patients with previously treated, locally advanced or metastatic Cholangiocarcinoma with an Isocitrate DeHydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. TIBSOVO® is a product of Servier Pharmaceuticals, LLC.
OPDIVO® (Nivolumab)
The FDA on August 19, 2021 approved OPDIVO® for the adjuvant treatment of patients with Urothelial Carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. OPDIVO® is a product of Bristol-Myers Squibb Co.
JEMPERLI® (Dostarlimab-gxly)
The FDA on August 18, 2021 granted accelerated approval to JEMPERLI® for adult patients with MisMatch Repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. JEMPERLI® is a product of GlaxoSmithKline LLC.
WELIREG® (Belzutifan)
The FDA on August 13, 2021 approved WELIREG®, a Hypoxia-Inducible Factor inhibitor for adult patients with Von Hippel-Lindau (VHL) disease who require therapy for associated Renal Cell Carcinoma (RCC), Central Nervous System (CNS) Hemangioblastomas, or Pancreatic NeuroEndocrine Tumors (pNET), not requiring immediate surgery. WELIREG® is a product of Merck & Co.